A Dose Ranging Study of the Aeris Polymeric Lung Volume Reduction (PLVR) System in Patients With Advanced Upper Lobe Predominant Emphysema

October 20, 2011 updated by: Aeris Therapeutics
This is a multi-center, open-label, non-controlled Pilot Study. Approximately 24 patients will be assigned to one of 3 treatment groups (8 patients each group). Patients in each group will receive 2, 4, and 6 (3 followed by a retreatment of 3) subsegmental treatments, respectively. All patients will receive treatment in a single lung under conscious sedation or general anesthesia. Patients will be followed for 24 weeks after completion of PLVR treatment(s). Upon completion of 12-week follow-up, all safety and efficacy data will be analyzed to determine an effective treatment dose. Thereafter, Group 1 patients may elect to be retreated at additional sites so that their total dose received is consistent with the effective dose. All study patients will receive standard medical therapy in addition to PLVR.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Berka, Germany
        • Chefarzt Klinik für Pneumologie
      • Berlin, Germany
        • Charité Universitätsmedizin Medizinische Klinik Infektiologie und Pulmologie
      • Grosshansdorf, Germany
        • Pneumologisches Forschungsinstitut
      • Heidelberg, Germany
        • Thoraxklinik Heidelberg
      • Hemer, Germany
        • Lungenklinik Hemer
      • Munich, Germany
        • Medizinische Klinik und Poliklinik Klinikum Großhadern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients must have a diagnosis of advanced upper lobe predominant (ULP) emphysema or advanced disease in the superior lower lobes as defined by FEV1/FVC <70 % predicted, FEV1 of < 50% predicted, TLC > 100% of predicted, and RV > 135% predicted.
  • Patients must have persistent symptoms despite medical therapy and either not be candidates for Lung Volume Reduction Surgery (LVRS) or have elected not to undergo LVRS.
  • Patients must be > 40 years of age, have symptoms despite medical therapy, and have none of the pre-specified co-morbid conditions that could influence study outcomes or their ability to tolerate bronchoscopy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PLVR
Device: Polymeric Lung Volume Reduction System (PLVR)
20ml (each) of polymer will be injected into 2, 3 or 4 subsegments during the first treatment. Eligible patients may have 20ml (each) of polymer will be injected into 2 or 3 subsegments during the second treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the ratio of Residual Volume (RV) to Total Lung Capacity (TLC)
Time Frame: 12 and 24 weeks following treatment
Change from baseline in RV/TLC ratio at 12 and 24 weeks following treatment
12 and 24 weeks following treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Forced Expiratory Volume in 1 Second (FEV1)
Time Frame: 12 and 24 weeks following treatment
o Change from baseline in FEV1 (post bronchodilator) at 12 and 24 weeks following treatment
12 and 24 weeks following treatment
Change in Forced Vital Capacity (FVC)
Time Frame: 12 and 24 weeks following treatment
Change from baseline in FVC (post bronchodilator) at 12 and 24 weeks following treatment
12 and 24 weeks following treatment
Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLco)
Time Frame: 12 and 24 weeks following treatment
Change from baseline in DLco at 12 and 24 weeks following treatment
12 and 24 weeks following treatment
Change in Medical Research Council Dyspnea (MRCD) score
Time Frame: 12 and 24 weeks following treatment
Change from baseline in MRCD score at 12 and 24 weeks
12 and 24 weeks following treatment
Change in distance walked in six minutes
Time Frame: 12 and 24 weeks following treatment
Change from baseline at 12 and 248 weeks in 6 Minutes Walk Test (6MWT)
12 and 24 weeks following treatment
Change in St. George's Respiratory Questionnaire (SGRQ) domain score
Time Frame: 12 and 24 weeks following treatment
Change from baseline in disease-specific health related quality of life assessment (SGRQ) at 12 and 24 weeks following treatment
12 and 24 weeks following treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aeris Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

April 20, 2009

First Submitted That Met QC Criteria

April 20, 2009

First Posted (Estimate)

April 21, 2009

Study Record Updates

Last Update Posted (Estimate)

October 21, 2011

Last Update Submitted That Met QC Criteria

October 20, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-C08-003PLV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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